Intravenous Anesthesia with Ciprofol and Remimazolam Besylate for Painless Gastroscopy: A Prospective, Single-Center, Randomized Controlled Trial.

IF 5.1 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-09-10 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S534842

Lin Li, Yusi Zhu, Jie Zhu, Mingyue Zeng, Yu Duan, Pengfei Cheng, Xiang Zhou

{"title":"Intravenous Anesthesia with Ciprofol and Remimazolam Besylate for Painless Gastroscopy: A Prospective, Single-Center, Randomized Controlled Trial.","authors":"Lin Li, Yusi Zhu, Jie Zhu, Mingyue Zeng, Yu Duan, Pengfei Cheng, Xiang Zhou","doi":"10.2147/DDDT.S534842","DOIUrl":null,"url":null,"abstract":"Purpose: To evaluate whether combining ciprofol and remimazolam offers superior safety and efficacy compared to propofol or ciprofol monotherapy for sedation during painless gastroscopy. We hypothesize improved hemodynamic and respiratory stability with the combination.Methods: A total of 641 patients undergoing gastroscopy were randomly assigned to one of three groups. Group P (Propofol) received an intravenous bolus of propofol at a dose of 1.5 mg/kg. Group CR (Ciprofol + Remimazolam) received an initial intravenous dose of remimazolam (0.08 mg/kg), followed by ciprofol (0.25 mg/kg). Group C (Ciprofol) received an intravenous bolus of ciprofol at a dose of 0.4 mg/kg. Sedation depth was maintained within the target range (Bispectral Index 40-60) through the administration of supplemental doses: propofol (10-20 mg boluses) in Group P, and ciprofol (2.5-5 mg boluses) in Groups CR and C.Results: Compared with group P, groups CR and C demonstrated significantly lower incidences of hypotension (CR: 7.8% vs P: 21.6%; C: 12.3% vs P: 21.6%; all P values < 0.001), mild hypoxia (CR: 8.8% vs P: 18.1%, P = 0.005; C: 7.7% vs P: 18.1%, P=0.001), and severe hypoxia (CR: 4.6% vs P: 9.8%, P = 0.038; C: 4.1% vs P: 9.8%, P = 0.020). Group C exhibited significantly longer induction time (1.62 ± 0.66 min, P < 0.001), recovery time (13.73 ± 3.82 min, P < 0.001), and operating room time (23.05 ± 6.38 min, P < 0.001) compared to both other groups. Additionally, gastroenterologist and anesthesiologist satisfaction was significantly higher in group CR than in groups P and C (all P values < 0.001).Conclusion: The combination of ciprofol and remimazolam exerts a lesser impact on the respiration and circulation of patients undergoing gastroscopy, and demonstrates superior safety and efficacy compared to the use of propofol or ciprofol alone.","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"8083-8095"},"PeriodicalIF":5.1000,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433632/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S534842","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: To evaluate whether combining ciprofol and remimazolam offers superior safety and efficacy compared to propofol or ciprofol monotherapy for sedation during painless gastroscopy. We hypothesize improved hemodynamic and respiratory stability with the combination.

Methods: A total of 641 patients undergoing gastroscopy were randomly assigned to one of three groups. Group P (Propofol) received an intravenous bolus of propofol at a dose of 1.5 mg/kg. Group CR (Ciprofol + Remimazolam) received an initial intravenous dose of remimazolam (0.08 mg/kg), followed by ciprofol (0.25 mg/kg). Group C (Ciprofol) received an intravenous bolus of ciprofol at a dose of 0.4 mg/kg. Sedation depth was maintained within the target range (Bispectral Index 40-60) through the administration of supplemental doses: propofol (10-20 mg boluses) in Group P, and ciprofol (2.5-5 mg boluses) in Groups CR and C.

Results: Compared with group P, groups CR and C demonstrated significantly lower incidences of hypotension (CR: 7.8% vs P: 21.6%; C: 12.3% vs P: 21.6%; all P values < 0.001), mild hypoxia (CR: 8.8% vs P: 18.1%, P = 0.005; C: 7.7% vs P: 18.1%, P=0.001), and severe hypoxia (CR: 4.6% vs P: 9.8%, P = 0.038; C: 4.1% vs P: 9.8%, P = 0.020). Group C exhibited significantly longer induction time (1.62 ± 0.66 min, P < 0.001), recovery time (13.73 ± 3.82 min, P < 0.001), and operating room time (23.05 ± 6.38 min, P < 0.001) compared to both other groups. Additionally, gastroenterologist and anesthesiologist satisfaction was significantly higher in group CR than in groups P and C (all P values < 0.001).

Conclusion: The combination of ciprofol and remimazolam exerts a lesser impact on the respiration and circulation of patients undergoing gastroscopy, and demonstrates superior safety and efficacy compared to the use of propofol or ciprofol alone.

Abstract Image

查看原文本刊更多论文

环丙酚和苯磺酸雷马唑仑静脉麻醉用于无痛胃镜检查：一项前瞻性、单中心、随机对照试验。

目的：评价与异丙酚或环丙酚单药相比，环丙酚联合雷马唑仑用于无痛胃镜检查镇静是否具有更高的安全性和有效性。我们假设联合用药可以改善血液动力学和呼吸稳定性。方法：641例胃镜检查患者随机分为三组。P组（异丙酚）静脉注射异丙酚，剂量为1.5 mg/kg。CR组（环丙酚+雷马唑仑）初始静脉给药雷马唑仑（0.08 mg/kg），随后给药环丙酚（0.25 mg/kg）。C组（环丙酚）静脉注射环丙酚，剂量为0.4 mg/kg。结果：与P组比较，CR组和C组的低血压发生率（CR: 7.8% vs P: 21.6%; C: 12.3% vs P: 21.6%， P值均< 0.001）、轻度缺氧发生率(CR: 8.8% vs P: 18.1%, P = 0.005；C: 7.7% vs P: 18.1%， P=0.001)和重度缺氧（CR: 4.6% vs P: 9.8%， P= 0.038; C: 4.1% vs P: 9.8%， P= 0.020）。C组诱导时间（1.62±0.66 min, P < 0.001）、恢复时间（13.73±3.82 min, P < 0.001）、手术室时间（23.05±6.38 min, P < 0.001）均显著高于其他两组。此外，CR组胃肠科医生和麻醉科医生的满意度显著高于P组和C组（P值均< 0.001）。结论：环丙酚与雷马唑仑联用对胃镜检查患者呼吸和循环的影响较小，且安全性和有效性优于单独使用异丙酚或环丙酚。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.